Morphine Sulfate extended-Release Tablets, USP; 30 mg, 100-count bottles, Rx only, manufactured by: Ohm Laboratories Inc., New Brunswick NJ 08901 USA; Relabeled by: Bryant Ranch Prepack, Inc., Burbank, CA, 91504 USA, NDC: 63629-1088-01. Class I

Reason: Labeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets contain Morphine Sulfate 30 mg Extended-Release tablets and bottles labeled as Morphine Sulfate 30 mg Extended-Release tablets may contain Morphine Sulfate 60 mg Extended-Release tablets.

Bryant Ranch Prepack, Inc. 20220617 Terminated
Distributed: Distributed to one wholesaler in AL for further distribution in the US.
Estriol 1mg/gm, Vaginal Cream, 60 gm tube, Qty: 1, Wedgewood Village Pharmacy LLC, 405 Heron Drive, Ste 200, Swedesboro, NJ 08085 Class II

Reason: Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection

Wedgewood Village Pharmacy, LLC 20220610 Terminated
Distributed: Products were distributed nationwide in the USA.
Estriol 1mg/gm, Vaginal Cream, 30 gm tube, Qty: 1, Wedgewood Village Pharmacy LLC, 405 Heron Drive, Ste 200, Swedesboro, NJ 08085 Class II

Reason: Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection

Wedgewood Village Pharmacy, LLC 20220610 Terminated
Distributed: Products were distributed nationwide in the USA.
Boric Acid 600 mg per suppository, 14 Vaginal Suppositories per box, Wedgewood Village Pharmacy LLC, 405 Heron Drive, Ste 200, Swedesboro, NJ 08085 Class II

Reason: Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection

Wedgewood Village Pharmacy, LLC 20220610 Terminated
Distributed: Products were distributed nationwide in the USA.
Boric Acid 600 mg capsules, 14 capsules per box, Qty: 1, Wedgewood Village Pharmacy LLC, 405 Heron Drive, Ste 200, Swedesboro, NJ 08085 Class II

Reason: Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection

Wedgewood Village Pharmacy, LLC 20220610 Terminated
Distributed: Products were distributed nationwide in the USA.
Doxycycline (as Calcium) (equivalent to 50mg/5mL), 10 mg/ml, 60 ml suspension bottles, Peppermint, Qty: 1, Wedgewood Village Pharmacy LLC, 405 Heron Dr, Ste 200, Swedesboro, NJ 08085 Class II

Reason: Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection

Wedgewood Village Pharmacy, LLC 20220610 Terminated
Distributed: Products were distributed nationwide in the USA.
Bethanechol Chloride 1mg/ml, 80 ml Suspension bottles Banana/Strawberry, Qty:1, Wedgewood Village Pharmacy LLC, 405 Heron Dr. Ste 200, Swedesboro, NJ 08085 Class II

Reason: Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection

Wedgewood Village Pharmacy, LLC 20220610 Terminated
Distributed: Products were distributed nationwide in the USA.
Enalapril Maleate Tablets, USP; 20 mg; 90 tablets, NDC 60429-186-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA. Class II

Reason: CGMP Deviations

Golden State Medical Supply Inc. 20220316 Ongoing
Distributed: Nationwide in the U.S: PA, MA, OH, TX, IL, ND, HI
Enalapril Maleate Tablets, USP; 10 mg; 90 tablets, NDC 60429-185-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA. Class II

Reason: CGMP Deviations

Golden State Medical Supply Inc. 20220316 Ongoing
Distributed: Nationwide in the U.S: PA, MA, OH, TX, IL, ND, HI
Enalapril Maleate Tablets, USP; 5 mg; 90 tablets, NDC 60429-184-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA. Class II

Reason: CGMP Deviations

Golden State Medical Supply Inc. 20220316 Ongoing
Distributed: Nationwide in the U.S: PA, MA, OH, TX, IL, ND, HI
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