Famotodine Tablets, USP, 20 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-936-01), B) 100 Count Bottles(NDC: 64679-936-02), and C) 1000 Count Bottles (NDC: 64679-936-03), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by

FDA recall notice · announced July 29, 2015 · Wockhardt

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Famotodine Tablets, USP, 20 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-936-01), B) 100 Count Bottles(NDC: 64679-936-02), and C) 1000 Count Bottles (NDC: 64679-936-03), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

Reason for recall

CGMP Deviations: Firm did not adequately investigate customer complaints.

Notes

Distribution: U.S. Nationwide including Puerto Rico.
Lot/code information: A) Lot #: LM10708, Expiry: 4/30/2015; Lot #: LM10859, Expiry: 5/31/2015; Lot #: LM11200, Expiry: 7/31/2015; Lot #: LM11679, Expiry: 9/30/2015; Lot #: LN10465, Expiry: 1/31/2016; Lot #: LN10750, Expiry: 3/31/2016; Lot #: LN11385, Expiry: 9/30/2016. B) Lot #: LM10709, Expiry: 4/30/2015; Lot #: LM10719, Expiry: 4/30/2015; Lot #: LM10721, Expiry: 4/30/2015; Lot #: LM10827, Expiry: 5/31/2015; Lot #: LM10828, Expiry: 5/31/2015; Lot #: LM10912, Expiry: 5/31/2015, Lot #: LM11205, Expiry: 7/31/2015; Lot #: LM11206, Expiry: 7/31/2015, Lot #: LM11239. Expiry: 7/31/2015; Lot #: LM11680, Expiry: 9/30/2015; Lot #: LM11822, Expiry: 10/31/2015; Lot #: LM11993, Expiry: 10/31/2015; Lot #: LN10114, Expiry: 12/31/2015; Lot #: LN10115, Expiry: 12/31/2015; Lot #: LN10695, Expiry: 3/31/2016; Lot #: LN10696, Expiry: 3/31/2016; Lot #: LN10697, Expiry: 3/31/2016; Lot #: LN10745, Expiry: 3/31/2016; Lot #: LN10749, Expiry: 3/31/2016; Lot #: LN11249, Expiry: 6/30/2016; Lot #: LN11374, Expiry: 8/31/2016; Lot #: LN11376, Expiry: 8/31/2016; Lot #: LN11382, Expiry: 7/31/2016; Lot #: LN11386, Expiry: 9/30/2016. C) Lot #: LM10685, Expiry: 4/30/2015; Lot #: LM10687, Expiry: 4/30/2015; Lot #: LM10691, Expiry: 4/30/2015; Lot #: LM10692, Expiry: 4/30/2015; Lot #: LM10707, Expiry: 4/30/2015; Lot #: LM10735, Expiry: 4/30/2015; Lot #: LM10741, Expiry: 4/30/2015; Lot #: LM10743, Expiry: 4/30/2015; Lot #: LM10860, Expiry: 5/31/2015; Lot #: LM10861, Expiry: 5/31/2015; Lot #: LM10862, Expiry: 5/31/2015; Lot #: LM10869, Expiry: 5/31/2015; Lot #: LM10911, Expiry: 5/31/2015; Lot #: LM11158, Expiry: 4/30/2015; Lot #: LM12039, Expiry: 10/31/2015; Lot #: LN10426, Expiry: 1/31/2016; Lot #: LN10427, Expiry: 1/31/2016; Lot #: LN10428, Expiry: 1/31/2016; Lot #: LN10435, Expiry: 1/31/2016; Lot #: LN10463, Expiry: 1/31/2016; Lot #: LN10464, Expiry: 1/31/2016; Lot #: LN10674, Expiry: 3/31/2016; Lot #: LN10675, Expiry: 3/31/2016; Lot #: LN10676, Expiry: 3/31/2016; Lot #: LN10751, Expiry: 3/31/2016; Lot #: LN11017, Expiry: 5/
Quantity: A) 69,008 Bottles, B) 399,730 Bottles, and C) 58,116 Bottles.
Status: Terminated
Products in this recall event:
- Famotodine Tablets, USP, 20 mg Tablets, For Repacking Only, Packaged in 6500 Count Drums, Over the Counter. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Wate (D-1266-2015)
- Clarithromycin Tablets, USP, 500 mg Tablets, 60 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA (D-1249-2015)
- Famotodine Tablets, USP, 40 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-937-01), B) 100 Count Bottles (NDC: 64679-937-02), and C) 1000 Count Bottles (NDC: 64679-937-03), Rx only. Manufactu (D-1250-2015)
- Metoprolol Succinate Extended-Release Tablets, USP, 50 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0735-02), B) 500 Count Bottles (NDC: 64679-0735-03), C) 4000 Count Pouches, For Repackin (D-1271-2015)
- Zolpidem Tartrate Tablets, 10 mg Tablets, CIV, Packaged in A) 100 Count Bottles (NDC: 64679-715-01) and B) 500 Count Bottles (NDC: 64679-715-04), Rx only. Manufactured by: Wockhardt Limited, Mumbai, I (D-1262-2015)
- Lisinopril Tablets USP, 40 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-942-01), B) 500 Count Bottles (NDC: 64679-942-05), and C) 1000 Count Bottles (NDC: 64679-942-02), Rx Only. Manufactu (D-1261-2015)
- Amlodipine Besylate Tablets, 10 mg Tablets, Packaged as A) 90 Count Bottles (NDC: 64679-423-01) and B) 1000 Count Bottles (NDC: 64679-423-02, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India (D-1256-2015)
- Lisinopril Tablets USP, 20 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-941-01), B) 500 Count Bottles (NDC: 64679-941-05), and C) 1000 Count Bottles (NDC: 64679-941-06), Rx Only. Manufactu (D-1259-2015)
- Amlodipine Besylate Tablets, 2.5 mg Tablets, Packaged in 90 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, (D-1243-2015)
- Azithromycin Tablets, USP, 500 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-0964-01) and B) 3 x 3 Tablet Card Cartons (NDC: 64679-964-05), Rx only. Manufactured by: Wockhardt Limited, Mumba (D-1263-2015)
- Extended Phenytoin Sodium Capsules, USP, 100 mg Capsules, Packaged as A) 100 Count Bottles (NDC: 64679-720-01) and B) 1000 Count Bottles (NDC: 64679-720-02), Rx Only. Manufactured by: Wockhardt Limite (D-1246-2015)
- Tamsulosin Hydrochloride Capsules, USP*, 0.4 mg Capsules, Packaged in A) 100 Count Bottles (NDC: 64679-516-02) and B) 500 Count Bottles (NDC: 64679-516-03), Rx Only. Manufactured by: Wockhardt Limited (D-1253-2015)
- Lamotrigine Extended-Release Tablets, 25 mg Tablets, 30 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 0 (D-1245-2015)
- Azithromycin Tablets, USP, 250 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-0961-01), B) 3,500 Count Pouches (NDC: 64679-961-08), and C) 3 x 6 Tablet Card Cartons (NDC: 64679-961-05), Rx on (D-1248-2015)
- Lisinopril Tablets USP, 2.5 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-927-01) and B) 500 Count Bottles (NDC: 64679-927-05), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. D (D-1244-2015)
- Metoprolol Succinate Extended-Release Tablets, USP, 25 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0734-02), B) 500 Count Bottles (NDC: 64679-0734-03), C) 8000 Count Pouches, For Repackin (D-1272-2015)
- Metoprolol Succinate Extended-Release Tablets, USP, 200 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0737-02) and B) 500 Count Bottles (NDC: 64679-0737-03), Rx Only. Manufactured by: Wockh (D-1252-2015)
- Captopril Tablets, USP, 25 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0903-01) and B) 1000 Count Bottles (NDC: 64679-0903-02), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. (D-1275-2015)
- Zonisamide Capsules, 50 mg Capsules, Packaged in 100 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 0705 (D-1273-2015)
- Lansoprazole Delayed-Release Capsules, USP, 15 mg Capsules, For Repackaging Only, Packaged in 4500 Count Pouches, Over the Counter. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: W (D-1251-2015)
- Azithromycin Tablets, USP, 600 mg Tablets, Packaged in 30 Count Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ (D-1264-2015)
- Lisinopril Tablets USP, 5 mg Tablets,Packaged in A) 100 Count Bottles (NDC: 64679-928-01), B) 500 Count Bottles (NDC: 64679-928-05), and C) 1000 Count Bottles (NDC: 64679-928-06), Rx Only. Manufacture (D-1257-2015)
- Lansoprazole Delayed-Release Capsules, USP, 15 mg Capsules, Packaged in 30 Count Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blv (D-1268-2015)
- Zolpidem Tartrate Tablets, 5 mg Tablets, CIV, Packaged in 100 Tablet Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippan (D-1247-2015)
- Captopril Tablets, USP, 100 mg Tablets, Packaged in 100 Count Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 0 (D-1277-2015)
- Lansoprazole Delayed-Release Capsules, USP, 30 mg Capsules, Packaged in A) 30 Count Bottles (NDC: 64679-0670-01), B) 90 Count Bottles (NDC: 64679-0670-07), and C) 1000 Count Bottles (NDC: 64679-0670-0 (D-1269-2015)
- Zonisamide Capsules, 25 mg Capsules, Packaged in 100 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 0705 (D-1274-2015)
- Amlodipine Besylate Tablets, 5 mg Tablets, Packaged as A) 90 Count Bottles (NDC: 64679-422-01) and B) 1000 Count Bottles (NDC: 64679-422-02), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India (D-1255-2015)
- Zonisamide Capsules, 100 mg Capsules, Packaged in 100 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 070 (D-1254-2015)
- Captopril Tablets, USP, 50 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0904-01) and B) 1000 Count Bottles (NDC: 64679-0904-02), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. (D-1276-2015)
- Metoprolol Succinate Extended-Release Tablets, USP, 100 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0736-02), B) 500 Count Bottles (NDC: 64679-0736-03), and C) 12 x 30 Tablet Dispenser Pa (D-1270-2015)
- Lisinopril Tablets USP, 30 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-953-01) and B) 500 Count Bottles (NDC: 64679-953-05), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Di (D-1260-2015)
- Famotodine Tablets, USP, 10 mg Tablets, For Repacking Only, Packaged in 50,000 Count Drums, Over the Counter. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Wa (D-1267-2015)
- Lisinopril Tablets USP, 10 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-929-01), B) 500 Count Bottles (NDC: 64679-929-05), and C) 1000 Count Bottles (NDC: 64679-929-06), Rx Only. Manufactu (D-1258-2015)
- Famotodine Tablets, USP, 20 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-936-01), B) 100 Count Bottles(NDC: 64679-936-02), and C) 1000 Count Bottles (NDC: 64679-936-03), Rx only. Manufactur (D-1265-2015)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.